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A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
RecruitingPhase 1
A Phase 1, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants With Platinum-Resistant Ovarian Cancer
Who can join
Ages 18 and older · Women
Full eligibility criteria
Key Inclusion Criteria: * Participants must have a histopathologically confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Key Exclusion Criteria: * Participants with primary platinum-refractory disease. Note: Other protocol-defined inclusion/exclusion criteria may apply.
About the study
This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants with platinum-resistant ovarian cancer.
What is being tested
- MEN2501 (drug)
Sponsor: Stemline Therapeutics, Inc. · Participants: 100 · Started: Jan 10, 2026
Contact the study team
- Stemline Trials · Phone: 1-877-332-7961
Official record on ClinicalTrials.gov — NCT07226427
Locations in the U.S.
| Arkansas | Highlands Oncology Group, Springdale |
| Connecticut | Yale University, New Haven |
| Florida | Florida Cancer Specialists & Research Institute, Sarasota |
| Massachusetts | Massachusetts General Hospital, Boston |
| Michigan | Karmanos Cancer Institute, Detroit |
| Minnesota | Mayo Clinic, Rochester |
| Virginia | NEXT Virginia, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.